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Analytical Laboratory of GEROPHARM R&D Center Received an Accreditation Certificate

9 September 2013

Test Analytical Laboratory of ZAO Pharm Holding (R&D Center of GEROPHARM, GC) has been accredited by the Federal Accreditation Service (Rosakkreditatsiya) for performance of testing according to the scope of accreditation. Accreditation Certificate РОСС RU.0001.22ФЛ45

The Accreditation Certificate is an evidence of technical competence of the analytical laboratory and allows to consider the research results legitimate.

The expert group reviewed the analytical laboratory of GEROPHARM R&D Center for compliance with the criteria established by the order of the Ministry of Economic Development of Russia. The commission evaluated such parameters as qualification and work experience of personnel, availability of test equipment, measuring devices and standard samples. The laboratory workers performed control tests on samples before the commission to determine the technical competence as well as to ensure the objectiveness of measurements and quality of tests. Experts also found that the quality management system implemented in the R&D Center meets all the requirements of accreditation.

The equipment available in the test analytical laboratory allows to solve a variety of problems in analysing finished dosage forms and active pharmaceutical ingredients. The laboratory has a wide range of chromatographic and spectral equipment for physical and chemical analysis, as well as the auxiliary equipment, which provides a variety of sample preparation methods, equipment for monitoring physical parameters of finished dosage forms, environmental chambers for stability studies of the drugs being developed. A highly experienced personnel of the analytical laboratory at GEROPHARM R&D Center has deep knowledge in drug quality control.

The main responsibility of the R&D Center’s analytical laboratory is to monitor all stages of development of production technology and innovative compositions of the finished drugs and pharmaceutical substances, as well as to develop and validate the analytical methods used for quality control of pharmaceutical products and substances. The laboratory has a high-tech equipment which allows to evaluate pharmaceutical products and substances under various parameters.

Currently, GEROPHARM R&D Center includes 4 high-tech laboratories; the synthetic and analytical laboratories, laboratory for development of finished dosage forms and genetic engineering.

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